LightScalpel - June 29, 2016
Issue Date
Jun 29, 2016
Region
Pacific
Category
Device
$117.00
Contact Name
David B. Walters
Contact Title
General Manager
Address 1
16932 Woodinville Redmond Rd. NE
Address 2
Suite A107
City
Woodinville
State
WA
Zip/Postal Code
98072-6980
Country
United States
Inspection Range
Jun 22, 2016 - Jun 29, 2016
Pages
3
First Observation
The written MDR Procedure does not include an internal system which provides for the timely and
effective evaluation of events that may be subject to medical device reporting requirements.
Investigator(s): Stephen R. Souza